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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MICROMARK BIOPSY SITE IDENTIFIER

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DEVICOR MEDICAL PRODUCTS, INC. MICROMARK BIOPSY SITE IDENTIFIER Back to Search Results
Model Number C1535J
Device Problems Positioning Failure (1158); Activation, Positioning or SeparationProblem (2906); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/18/2017
Event Type  malfunction  
Manufacturer Narrative
The micromark ii tissue marker tissue marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure. One c1535 was received for investigation on 2/28/2017 and analyzed on 3/23/2017. Device was found to be in fair condition. Evidence of use in a procedure was present on the marker. Marker device is intact with the marker clip deployed. Marker clip was received in vial with breast tissue attached. Device functionality check was unable to be confirmed since the clip was already deployed. The device history records were reviewed and there were no non-conformances that would relate to this failure. Due to the discovery of the tissue, the reportability was reassessed against the result of the investigation. Following consultation with our medical director, due to the potential to cause or contribute to death or serious injury as a result of potential missed or lost tissue samples, pursuant to 21 cfr §803, this failure mode was determined to be a reportable malfunction. Thus, we are submitting this medwatch report.
 
Event Description
The (b)(4) affiliate reported that after completion of retrieving tissues, the doctor tried to deploy the clip. However the clip was not released.
 
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Brand NameMICROMARK
Type of DeviceBIOPSY SITE IDENTIFIER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC.
300 e-business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEXICO
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california 22440
MX 22440
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key6513629
MDR Text Key73463302
Report Number3008492462-2017-00028
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K013413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2020
Device Model NumberC1535J
Device Catalogue NumberC1535
Device Lot NumberF11524314D1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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